Status:
RECRUITING
A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
Lead Sponsor:
Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
Conditions:
Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
3-25 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
Eligibility Criteria
Inclusion
- The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
- Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
- Documentation of CD19/CD22 tumor expression
- 3\. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \>3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.
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Exclusion
- Active CNS involvement by malignancy；
- Isolated extramedullary leukemia recurrence；
- Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
- Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.
- 4\. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.
- 7\. Other situations deemed inappropriate for participation in this study by the investigator.
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Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06927466
Start Date
September 19 2024
End Date
June 30 2028
Last Update
May 22 2025
Active Locations (8)
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1
Peking University People's Hospital
Beijing, China
2
Jiangxi Province pediatric hospital
Nanchang, China
3
The First Affiliated Hospital of Nanchang University
Nanchang, China
4
Children's Hospital of Shanghai
Shanghai, China